Tuina on knee pain and functional decline of lower limbs for patients with mild-to-moderate knee osteoarthritis in Shanghai: protocol for a multicentre, assessor-blinded, randomised controlled trial.

INTRODUCTION: Knee osteoarthritis (KOA) is one of the most common osteoarthritis, imposing substantial economic and medical burdens on both individuals and society. In China, Tuina has been selected as a complementary and alternative therapy to relieve knee pain and dysfunction symptoms. However, the current evidence is insufficient to support the efficacy of Tuina therapy in addressing knee pain and improving physical function. The trial aims to compare the effectiveness of Tuina with celecoxib, which is considered as the standard treatment, and to assess its potential as an alternative therapy through changes in outcome measures. METHODS AND ANALYSIS: A total of 360 KOA patients aged between 40 and 70 years and classified as Kellgren and Lawrence grades I-II will be recruited from eight subcentral hospitals. The participants will be randomly assigned to either the treatment group (Tuina, Biw) or the control group (celecoxib, Qd), with both groups undergoing a 4-week intervention phase followed by an 8-week follow-up phase. The primary outcome is the change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale at week 4 compared with baseline. Secondary outcomes including WOMAC stiffness and function subscales, WOMAC total score, 36-item Short-Form Health Survey, Timed Up and Go test, Short Physical Performance Battery, gait analysis parameters and pain medication records will be assessed at weeks 4, 8 and 12. Any adverse events that occur during the trial will be promptly recorded. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2023SHL-KY-16-01, 2023SHL-KY-16-02). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ChiCTR2300069416.

Effects of the Prolong Life With Nine Turn-Method Qigong on Fatigue, Insomnia, Anxiety, and Gastrointestinal Disorders in Patients With Chronic Fatigue Syndrome: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic fatigue syndrome (CFS) is a debilitating multisystem disorder that can lead to various pathophysiological abnormalities and symptoms, including insomnia, gastrointestinal disorders, and anxiety. Due to the side effects of currently available drugs, there is a growing need for safe and effective nondrug therapies. The Prolong Life With Nine Turn (PLWNT) Qigong method is a system of mind-body exercise with restorative benefits that can alleviate the clinical symptoms of CFS and impart a significant inhibitory effect. Various studies have proven the treatment efficacy of PLWNT; however, the impact on insomnia, gastrointestinal disorders, and anxiety in patients with CFS has not yet been investigated. OBJECTIVE: This study aims to evaluate the efficacy and safety of the PLWNT method in terms of its effects on fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. METHODS: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention and 8-week follow-up. A total of 208 patients of age 20-60 years will be recruited. The patients will be randomly divided into a PLWNT Qigong exercise group (PLWNT Group) and a control group treated with cognitive behavioral therapy at a ratio of 1:1. Participants from the treatment groups will be taught by a highly qualified professor at the Shanghai University of Traditional Chinese Medicine once a week and will be supervised via web during the remaining 6 days at home, over 12 consecutive weeks. The primary outcome will be the Multidimensional Fatigue Inventory 20, while the secondary outcomes include the Pittsburgh Sleep Quality Index, Gastrointestinal Symptom Rating Scale, Hospital Anxiety and Depression Scale, functional magnetic resonance imaging, gut microbiota, and peripheral blood. RESULTS: The study was approved by the ethics committee of Shanghai Municipal Hospital of Traditional Chinese Medicine in March 2022 (Ethics Approval Number 2022SHL-KY-05). Recruitment started in July 2022. The intervention is scheduled to be completed in December 2024, and data collection will be completed by the end of January 2025. Over the 3-year recruitment period, 208 participants will be recruited. Data management is still in progress; therefore, data analysis has yet to be performed. CONCLUSIONS: This randomized trial will evaluate the effectiveness of the PLWNT method in relieving fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. If proven effective, it will provide a promising alternative intervention for patients with CFS. TRIAL REGISTRATION: China Clinical Trials Registry ChiCTR2200061229; https://www.chictr.org.cn/showproj.html?proj=162803. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53347.

Effect of Prolong-life-with-nine-turn-method (Yan Nian Jiu Zhuan) Qigong on fatigue and gastrointestinal function in patients with chronic fatigue syndrome: Study protocol for a randomized controlled trial.

INTRODUCTION: Chronic fatigue syndrome (CFS) is a physical and mental disorder in which long-term fatigue is the main symptom. CFS patients are often accompanied by functional gastrointestinal diseases (FGIDs), which lead to decreased quality of life and increased fatigue. Prolong-life-with-nine-turn-method (PLWNT) is a kind of physical and mental exercise. Its operation includes adjusting the mind, breathing and cooperating with eight self-rubbing methods and one upper body rocking method. PLWNT was used to improve the digestive function in ancient China and to treat FGIDs such as functional dyspepsia and irritable bowel syndrome in modern times. Previous studies have shown that PLWNT can reduce fatigue in patients with CFS. But it is unclear whether the effect of PLWNT on CFS fatigue is related to gastrointestinal function. The aim of this study was to explore the relationship between PLWNT and fatigue and gastrointestinal function in patients with CFS. METHODS: This study is a non-inferiority randomized controlled trial (RCT). The whole study period is 38 weeks, including 2 weeks of baseline evaluation, 12 weeks of intervention and 6 months of follow-up. Ninety-six CFS patients will be stratified random assigned to the intervention group (PLWNT) and the control group (cognitive behavior treatment) in the ratio of 1:1 through the random number table generated by SPSS. In the evaluation of results, Multidimensional Fatigue Inventory-20 (MFI-20), Gastrointestinal Symptom Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), and Short Form 36 item health survey (SF-36) will be evaluated at week 0 (baseline), week 6 (midterm), week 12 (endpoint) and month 9 (follow up). The intestinal flora will be evaluated at week 0 (baseline) and week 12 (endpoint). The data results will be processed by statistical experts. The data analysis will be based on the intention to treat principle and per-protocol analysis. In the efficacy evaluation, repeated measurement analysis of variance will be used for data conforming to normal distribution or approximate normal distribution. The data which do not conform to the analysis of repeated measurement variance will be analyzed by the generalized estimation equation Linear discriminant analysis will be used to clarify the difference species of intestinal flora. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. DISCUSSION: This trial will provide evidence to PLWNT exerting positive effects on fatigue and gastrointestinal function of CFS. It will further explore whether the improvement of PLWNT on CFS fatigue is related to gastrointestinal function. TRIAL REGISTRATION: The trial was registered at Chinese Clinical Trial Registry http://www.chictr.org.cn/showproj.aspx?proj=151456 (Registration No.: ChiCTR2200056530). Date: 2022-02-07.

Global trends of traditional Chinese exercises for musculoskeletal disorders treatment research from 2000 to 2022: A bibliometric analysis.

Background: Traditional Chinese exercise has been shown to be effective in relieving long-term chronic pain, physical dysfunction, decreased ability to participate in society and decreased quality of life in musculoskeletal diseases. In recent years, there has been a steady increase in publications on the treatment of musculoskeletal disorders by traditional Chinese exercises. The purpose of this study is to review the characteristics and trends of Chinese traditional exercise studies on musculoskeletal diseases published since 2000 through bibliometric analysis, and identify current research hotspots, so as to guide the direction of future research. Methods: Publications regarding traditional Chinese exercises for musculoskeletal disorders from 2000 to 2022 were downloaded from the Web of Science Core Collection. VOSviewer 1.6.18 and CiteSpace V software were used for bibliometric analyses. Bibliometric visualization and comparative analysis were conducted for authors, cited authors, journals, co-cited journals, institutions, countries, references, and keywords. Results: A total of 432 articles were obtained, with an upward trend over time. The most productive countries and institutions in this field are the USA (183) and Harvard University (70). Evidence-based Complementary and Alternative Medicine (20) was the most prolific journal, Cochrane Database System Review (758) was the most commonly cited journal. Wang Chenchen published the largest number of articles (18). According to high frequency keywords, the hot spot musculoskeletal disorder and the type of traditional Chinese exercise are knee osteoarthritis and Tai Chi. Conclusion: This study provides a scientific perspective for the research of traditional Chinese exercises for musculoskeletal disorders and provides valuable information for researchers to discover the current research status, hot spots and new trends of future research.

Effectiveness of Tuina Therapy Combined With Yijinjing Exercise in the Treatment of Nonspecific Chronic Neck Pain: A Randomized Clinical Trial.

Importance: Both tuina therapy and yijinjing exercise were beneficial to patients with nonspecific chronic neck pain, but the evidence for this combination is limited. Objective: To investigate the effectiveness of tuina therapy combined with yijinjing exercise compared with tuina therapy alone for patients with nonspecific chronic neck pain. Design, Setting, and Participants: A 12-week, open-label, analyst-blinded randomized clinical trial (8-week intervention plus 4-week observational follow-up) was conducted from September 7, 2020, to October 25, 2021. A total of 102 participants with nonspecific chronic neck pain were recruited, and data were analyzed from December 10, 2021, to March 26, 2022. Interventions: Participants in the tuina group or tuina combined with yijinjing group received 3 sessions of tuina therapy per week for 8 weeks, for a total of 24 sessions. Participants in the tuina combined with yijinjing group practiced yijinjing 3 times a week for 8 weeks, including an instructor-guided exercise at the hospital and 2 self-practice exercises at home. Main Outcomes and Measures: The primary outcome was change in visual analog scale (VAS) score from baseline to week 8. Secondary outcomes included Neck Disability Index scores, Self-rating Anxiety Scale scores, tissue hardness, and active range of motion. Results: This randomized clinical trial recruited 102 patients (mean [SD] age, 36.5 [4.9] years; 69 [67.6%] female) who were randomized to 2 groups. All 102 patients (100%) completed all the outcome measurements. The mean difference in VAS scores from baseline at week 8 for the tuina combined with yijinjing group was -5.4 (95% CI, -5.8 to -5.1). At week 8, the difference in VAS score was -1.2 (95% CI, -1.6 to -0.8; P < .001) between the tuina group and the tuina combined with yijinjing group. The effectiveness of tuina combined with yijinjing in treating nonspecific chronic neck pain remained at the 12-week follow-up. Conclusions and Relevance: In this randomized clinical trial, for patients with nonspecific chronic neck pain, tuina combined with yijinjing was more effective than tuina therapy alone in terms of pain, functional recovery, and anxiety at week 8, and effectiveness remained at week 12. A combination of tuina and yijinjing should be considered in the management of nonspecific chronic neck pain. Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000036805.

Effects of the Prolong Life With Nine Turn Method (Yan Nian Jiu Zhuan) Qigong on Brain Functional Changes in Patients With Chronic Fatigue Syndrome in Terms of Fatigue and Quality of Life.

Background: Chronic fatigue syndrome (CFS) is characterized by persistent fatigue, which often leads to physical and psychological damage. The Prolong Life with Nine Turn method (PLWNT) Qigong is considered as one of the complementary treatments for improving symptoms in patients with CFS. In this study, we used functional magnetic resonance imaging (fMRI) to explore the effects of PLWNT intervention on the subjects with CFS. Methods: Thirty four CFS patients were randomly divided into PLWNT group and cognitive behavioral therapy (CBT) group. Both groups were taught by a highly qualified professor at the Shanghai University of Traditional Chinese Medicine once a week and were supervised online during the remaining 6 days at home, over 12 consecutive weeks. We calculated the regional rs-fMRI index amplitude of low-frequency fluctuations (ALFF) for all subjects. To study the changes of the brain network, we used the brain regions with significant differences in ALFF as the regions of interest for whole-brain functional connectivity (FC) analysis. The Multi-dimensional Fatigue Inventory 20 (MFI-20) and Short Form 36-item Health Survey (SF-36) were used for clinical symptom assessment to explore the possible correlation between the rs-fMRI indicators and clinical variations. Results: The ALFF values of the right superior frontal gyrus (SFG), and left median cingulate gyrus (DCG) were increased, whereas those of the left middle occipital gyrus (OG), right middle OG and left middle temporal gyrus (MTG) were decreased in PLWNT group. The FC values between the DCG and middle temporal gyrus (MTG), and those between the left OG and the right OG were enhanced. In addition, the SF-36 were positively with the left OG (r = 0.524), SFG (r = 0.517), and DCG (r = 0.533), MFI-20 were negatively with the SFG (r = -0.542) and DCG (r = -0.578). These results were all corrected by FWE (voxel level p < 0.001, cluster level p < 0.05). Conclusion: CFS patients have abnormal regional spontaneous neuronal activity and abnormal functional connections between regions after PLWNT intervention. PLWNT can relieve the fatigue symptoms of CFS patients and improve their quality of life. The study was registered in the American Clinical Trial Registry (12/04/2018). Registration Number is NCT03496961.

Association between physical activity and infertility: a comprehensive systematic review and meta-analysis.

BACKGROUND: Physical activity (PA) may protect against infertility by modulating the hypothalamic-pituitary-gonadal axis, thereby reducing gonadotropin levels, elevating immune function, and inhibiting inflammation and circulating sex hormones. However, whether PA reduces the risk of infertility remains largely unknown. We therefore conducted a systematic review and meta-analysis to determine the preventive effects of PA on infertility. METHODS: We searched PubMed, Cochrane Library, EMBASE, and CINAHL databases to retrieve published epidemiologic studies on the relationship between PA and infertility. Following the PRISMA guidelines, we selected English literature publishedprior to 11 April 2022, and assessed study quality using the Newcastle-Ottawa Scale. Our protocol, including the full methods employed for this review, is available on PROSPERO (ID = CRD42020143344). RESULTS: Six cohort studies and four case-control studies based on 708,965 subjects and 12,580 cases were eventually screened and retained. High levels of PA were shown to reduced risk of infertility relative to low levels (cumulative relative risk [RR] = 0.59, with a 95% confidence interval CI 0.49-0.71), and we reported results for cohort studies (RR = 0.63, 95% CI 0.50-0.79) and case-control studies (RR = 0.49, 95% CI 0.35-0.67). Our findings were comparable for men (RR = 0.65, 95% CI 0.41-1.04) and women (RR = 0.56, 95% CI 0.47-0.66). The meta-analysis of six risk estimates from five studies of low, moderate, and high PA levels showed that moderate PA may also reduce the risk of infertility compared with low PA (RR = 0.54, 95% CI 0.38-0.77). However, high PA also appeared to slightly augment the risk of infertility compared with moderate PA (RR = 1.31, 95% CI 1.08-1.59). CONCLUSIONS: This present systematic review comprehensively reflected an inverse relationship between different levels of PA and infertility, and our meta-analysis showed that a moderate-to-high PA level significantly reduced the overall risk of infertility, and that this level of PA activity was a common protective factor. In addition, limited evidence suggested that compliance with international PA guidelines would greatly lower the risk of infertility (RR = 0.58, 95% CI 0.45-0.74; I2 = 0.0%). Future studies, however, need to be executed to further determine the frequency, optimal dosage, and duration required to effectively attenuate the risk of infertility.

Efficacy of Yijinjing combined with Tuina for patients with non-specific chronic neck pain: study protocol for a randomized controlled trial.

BACKGROUND: Non-specific chronic neck pain (NCNP) is a common musculoskeletal disorder which has caused a huge economic burden due to its expensive health costs and high re-occurrence rate. Yijinjing and Tuina are widely used for non-specific chronic neck pain in China. But there is little scientific evidence to evaluate their efficacy for NCNP. The aim of this research is to compare the efficacy of Yijinjng combined with Tuina versus Tuina for patients with NCNP. METHODS/DESIGN: A randomized controlled trial in which 102 patients with non-specific chronic neck pain will be recruited and randomly allocated to either the Tuina group or the Yijinjng combined with Tuina group in a 1:1 ratio. The interventions for both groups will be carried out three times a week for 8 weeks. The patients in the two groups will receive follow-up 1 month after the intervention. The primary outcome will be the changes in the visual analog scale (VAS). Secondary outcomes will be measured by the Neck Disability Index (NDI), Self-Rating Anxiety Scale (SAS), and Tissue Hardness and Active Range of Motion (AROM). The data will be analyzed at the baseline, 4 weeks during the intervention, at the end of the intervention, and 1 month after the intervention. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. DISCUSSION: The purpose of this trial is to determine whether Yijinjing combined with Tuina is not inferior to Tuina for patients with NCNP. This study will provide clinicians and stakeholders much-needed knowledge for a complementary and alternative therapy for patients with non-specific chronic neck pain. TRIAL REGISTRATION: ChiCTR registry (ChiCTR) 2000036805 . Registered on August 25, 2020.

[Complex mechanisms of chronic pain in knee osteoarthritis identified by neuroimaging technology].

Chronic pain of knee osteoarthritis (KOA) greatly affects the quality of life and functional activities of patients. It is important to clarify the underlying mechanisms of KOA pain and the analgesic effect of different therapies. Neuroimaging technology has been widely used in the basic and clinical research of pain. In the recent years, neuroimaging technology has played an important role in the basic and clinical research of KOA pain. Increasing evidence demonstrates that chronic pain in KOA includes both nociceptive and neuropathic pain. The neuropathic mechanism involved in KOA pain is complex, which may be caused by peripheral or central sensitization. In this paper, we review the regional changes of brain pathophysiology caused by KOA pain based on magnetic resonance imaging (MRI), electroencephalogram (EEG), magnetoencephalogram (MEG), near-infrared spectroscopy (NIRS) and other neuroimaging techniques. We also discuss the central analgesic mechanism of different KOA therapies, with a focus on the latest achievements in the evaluation and prediction of pain. We hope to provide new thoughts for the treatment of KOA pain, especially in the early and middle stages of KOA.